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Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation (10-015)

This study is currently recruiting participants.
Verified March 2013 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01262729
First received: December 16, 2010
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

In this clinical trial will be checked, whether 2 hour ventilation with xenon has neuroprotective effects in patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation


Condition Intervention Phase
Efficacy and Safety of Xenon Inhalation
Successful Cardiopulmonary Resuscitation
Addition to Therapeutical Hypothermia
 Procedure: therapeutical hypothermia
Drug: Xenon Inhalation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Xenon and Therapeutical Hypothermia After Successful Cardiopulmonary Resuscitation

Resource links provided by NLM:

MedlinePlus related topics: CPR Hypothermia
U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Significant difference between treatment group and control group [ Time Frame: within 28 days after cardiac arrest ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and efficacy of xenon ventilation within 2 hours after successful cardiopulmonary resuscitation [ Time Frame: within 28 days after cardiac arrest ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenon-Arm
Patients in Xenon-Arm will be inhalated with xenon within 2 hours additionally to therapeutical hypothermia after successful cardiopulmonary resuscitation.
 Procedure: therapeutical hypothermia
Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)
Drug: Xenon Inhalation
Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia
Active Comparator: MTH
Patients after successful cardiopulmonary resuscitation will be treated only with therapeutical hypothermia
 Procedure: therapeutical hypothermia
Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)

Detailed Description:

Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation will be randomized in two groups. First group (Treatment group) will be inhalated with xenon within 2 hours in addition to therapeutical hypothermia. The second group (Control group) will be treated with therapeutical hypothermia in accordance to international guidelines.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with out of hospital cardiac arrest and successful cardiopulmonary resuscitation, which will be treated at Department of Internal Medicine I, University Hospital Aachen

Exclusion Criteria:

  • Patients younger than 18 years
  • Xenon allergy
  • Pregnancy
  • High expired oxygen requirement (>70%) in order to maintain adequate arterial oxygen saturation (SpO2>94%) at the beginning of treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262729

Contacts
Contact: Michael Fries, PD Dr. med. + 49 241 80 ext 80444 mfries@ukaachen.de
Contact: Margarita Gritzewski, M.Sc. + 49 241 80 ext 35664 mgritzewski@ukaachen.de

Locations
Germany
Surgical Intensive Care - Adults, University Hospital Aachen Recruiting
Aachen, NRW, Germany, 52074
Contact: Michael Fries, PD Dr. med.     +49 241 80 ext 80444     mfries@ukaachen.de    
Contact: Margarita Gritzewski, M.Sc.     + 49 241 80 ext 35664     mgritzewski@ukaachen.de    
Principal Investigator: Michael Freis, PD Dr. med.            
Sub-Investigator: Jörg Schröder, Dr. med.            
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Michael Fries, PD Dr. med. Surgical Intensive Care - Adults, University Hospital Aachen
  More Information

No publications provided by RWTH Aachen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01262729     History of Changes
Other Study ID Numbers: Xenon-MTH-Study, 2010-022679-71
Study First Received: December 16, 2010
Last Updated: March 21, 2013
Health Authority: Germany: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
xenon inhalation
therapeutical hypothermia
patients after cardiopulmonary resuscitation
efficacy
safety

Additional relevant MeSH terms:
Respiratory Aspiration
Hypothermia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Body Temperature Changes
Xenon
 Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013